Chargement en cours

Quality Manager (Lab Ops / GMP)

SURESNES, 92
il y a 2 jours

As our first dedicated Quality Manager, you will bridge the gap between high-speed innovation and rigorous regulatory compliance. Your mission is to design and implement a Quality Management System (QMS) that supports our increased production needs and ensures our new lab setup meets the gold standard for global veterinary medicine.

Main Responsibilities

QMS Design

  • Build from Scratch: Design, implement, and maintain a robust QMS compliant with applicable biotech and pharmaceutical guidelines.
  • Audit Leadership: Manage the internal audit program across all operational areas to ensure constant readiness.
  • Supply Chain Integrity: Oversee the qualification and auditing of all suppliers and subcontractors.
  • Knowledge Culture: Design and deliver training programs on documentation standards and quality procedures for the whole team.

GMP & Regulatory Support

  • Lab Setup: Lead all quality aspects of the incoming GMP lab setup, including site qualification, equipment validation, and cleanroom procedures.
  • Global Submissions: Act as a key pillar in the preparation of regulatory dossiers from a quality and GMP compliance perspective.
  • Release Authority: Ensure batch release procedures are defensible, rigorous, and in place for all products released to the field.

Monitoring & Continuous Improvement

  • Incident Response: Lead post-incident quality reviews following field deviations or high-mortality cases to ensure we never stop learning.
  • Early Integration: Participate in new product and process development, acting as a proactive voice to raise quality issues during the design phase rather than after.

What We’re Looking For

  • Education: Degree in Pharmacy, Biology, Biotechnology, or a related life science discipline.
  • Experience: Minimum 3-4 years in a quality role within a regulated biotech, pharma, or veterinary medicine environment.
  • Technical Skills: Solid working knowledge of GMP guidelines; familiarity with veterinary medicinal product regulations is a massive plus; proficiency in designing and managing QMS software and documentation.
  • Soft Skills: Comfortable with ambiguity, proactive in high-pressure situations, and able to translate complex regulations into clear team actions.
  • Languages: Fluent in English.

What We Offer

  • International Culture: Work with a global, diverse team driven by a shared vision of impactful biotechnology.
  • Impactful Work: Lead processes that contribute directly to innovative biotechnologies.
  • Growth & Learning: Gain valuable technical experience in a fast-paced environment.
  • Well-being Perks: Free breakfast, sports activities, and a healthy work-life balance culture.

If you’re excited by science with real-world impact and want to help rewrite the future of animal health—we’d love to chat.

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Entreprise
Entrepreneur First
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